Multi-Center Pilot Study of truSculpt Device

September 14, 2023 updated by: Cutera Inc.

This is an Exploratory Multi-center, Pilot Study to Evaluate the Safety, Efficacy and Ergonomics of Cutera truSculpt Device. Subjects May Receive up to Three Treatments and Will be Followed at 12 Weeks Post the First and Final Treatment.

An exploratory pilot study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multi-center, pilot study in approximately 40 subjects, ages 18 to 65. Subjects will receive treatments and will be followed at 12 weeks post final treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Brisbane, California, United States, 94005
        • Cutera Research Center
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Skin Associates of South Florida
    • Illinois
      • Naperville, Illinois, United States, 60563
        • The Dermatology Institute of DuPage Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subject must be able to read, understand and sign the Informed Consent Form.
  2. Female or Male, 18 to 65 years of age (inclusive).
  3. Subject has visible fat bulges in the area to be treated.
  4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
  5. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period.
  6. Subject must adhere to the follow-up schedule and study instructions.
  7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study.
  8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.
  9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.

Exclusion Criteria:

  1. Participation in a clinical trial of another device or drug within 3 months of study participation, or during the study period.
  2. Any type of prior cosmetic treatment to the target area within 6 months of study participation.
  3. Any prior invasive cosmetic surgery to the target area, such as liposuction.
  4. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
  5. Has metal implant(s) within the body, such as artificial heart valves.
  6. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
  7. History of any disease or condition that could impair wound healing.
  8. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
  9. Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion.
  10. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
  11. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: truSculpt
truSculpt treatment
Device: truSculpt
Subjects will receive utreatments and will be followed at 12 weeks post final treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body Fat Assessment by Investigator
Time Frame: 12 weeks post final treatment
Degree of Improvement in body fat as assessed by Investigator using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, and 0=No Change Higher scores indicate better outcomes
12 weeks post final treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Volumetric Comparison of Circumferential measurement in cm
Time Frame: Comparison of baseline to 12 weeks post first treatment, and to 12 weeks post final treatment
Difference in circumferential measurement in cm from baseline and at 12 weeks post first and final treatments.
Comparison of baseline to 12 weeks post first treatment, and to 12 weeks post final treatment
Ultrasound Comparison of Subcutaneous fat measurements
Time Frame: Comparison of baseline to 12 weeks post first treatment, and to 12 weeks post final treatment
Difference in Subcutaneous fat measurement from baseline and at 12 weeks post first and final treatment.
Comparison of baseline to 12 weeks post first treatment, and to 12 weeks post final treatment
Temporal Photo Identification
Time Frame: Comparison of Baseline to 12 weeks post first treatment, and to 12 weeks post final treatment
Correct identification of the 12 weeks post first and final treatment photographs from the baseline by at least two of the three blinded reviewers in 75% of the subjects.
Comparison of Baseline to 12 weeks post first treatment, and to 12 weeks post final treatment
Body Fat Assessment by blinded reviewer
Time Frame: At 12 weeks post first treatment and at 12 weeks post final treatment
Blinded improvement assessments of body fat as assessed by blinded reviewers using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement (76 - 100%), +3=Significant Improvement(51 - 75%), +2=Moderate Improvement (26 - 50%), +1=Mild Improvement (6 - 25%), and 0=No Change (0 - 5%) at 12 weeks post the first and final treatments
At 12 weeks post first treatment and at 12 weeks post final treatment
Body Fat Assessment by Investigator
Time Frame: At 12 weeks post first treatment and at 12 weeks post final treatment
Degree of Improvement in body fat as assessed by Investigator using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement (76 - 100%), +3=Significant Improvement(51 - 75%), +2=Moderate Improvement (26 - 50%), +1=Mild Improvement (6 - 25%), and 0=No Change (0 - 5%)
At 12 weeks post first treatment and at 12 weeks post final treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cutera Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashish Bhatia, MD, The Dermatology Institute of DuPage Medical Group
  • Principal Investigator: Joely Kaufman, MD, FAAD, Skin Associates of South Florida
  • Principal Investigator: Stephen Ronan, MD, Cutera Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C-17-TS16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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